Systems and methods for treating lumenal valves

ABSTRACT

The present embodiments relate to systems and methods for treating lumenal valves. Particularly, and in accordance with one aspect, the present disclosure is directed to methods and systems for partial or complete replacement of lumenal valves. An exemplary catheter in accordance with the disclosure includes an elongate body having a proximal end and a distal end, and a retractable sheath mounted on the elongate body proximate the distal end. The sheath and elongate body cooperating to define a first annularly-shaped compartment between the body and sheath. The catheter further includes a valve prosthesis mounted in the compartment, the prosthesis having proximal and distal ends connected to a means for deploying the valve prosthesis from the catheter.

CROSS-REFERENCE TO RELATED APPLICATION

This patent application claims the benefit of priority to U.S.Provisional Patent Application No. 61/249,020, filed on Oct. 6, 2009.The aforementioned patent application is incorporated by referenceherein in its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present embodiments relate to systems and methods for treatinglumenal valves. Particularly, and in accordance with one aspect, thepresent disclosure is directed to methods and systems for partial orcomplete replacement of lumenal valves.

2. Description of Related Art

Recently, there has been increasing consideration given to thepossibility of using, as an alternative to traditional cardiac-valveprostheses, valves designed to be implanted using minimally-invasivesurgical techniques or endovascular delivery (so-called “percutaneousvalves”). Implantation of a percutaneous valve is a far less invasiveact than the surgical operation required for implanting traditionalcardiac-valve prostheses.

These expandable prosthetic valves typically include an anchoringstructure or armature, which is able to support and fix the valveprosthesis in the implantation position, and prosthetic valve elements,generally in the form of leaflets or flaps, which are stably connectedto the anchoring structure and are able to regulate blood flow.

An advantage of these expandable prosthetic valves is that they enableimplantation using various minimally invasive or sutureless techniques.One application for such an expandable valve prosthesis is for aorticvalve replacement. Various techniques are generally known for implantingsuch an aortic valve prosthesis and include percutaneous implantation(e.g., transvascular delivery through a catheter), dissection of theascending aorta using minimally invasive thoracic access (e.g.,mini-thoracotomy), and transapical delivery wherein the aortic valveannulus is accessed directly through an opening near the apex of theleft ventricle. Note that the percutaneous and thoracic accessapproaches involve delivering the prosthesis in a direction opposingblood flow (i.e., retrograde), whereas the transapical approach involvesdelivering the prosthesis in the same direction as blood flow (i.e.,antegrade). Similar techniques may also be applied to implant such acardiac valve prosthesis at other locations (e.g., a pulmonary valveannulus).

However, to date, such systems have involved delivery of largeimplantable devices on catheters having very large profiles,necessitating unfavorable methods of delivery. There is thus a continuedneed in the art for devices and associated approaches for deliveringreplacement valves percutaneously with minimal adverse effects on thepatient. The presently disclosed embodiments provide solutions for theseneeds.

SUMMARY OF THE INVENTION

Advantages of the present invention will be set forth in and becomeapparent from the description that follows. Additional advantages of theinvention will be realized and attained by the methods and systemsparticularly pointed out in the written description and claims hereof,as well as from the appended drawings.

To achieve these and other advantages and in accordance with the purposeof the invention, as embodied herein, in one aspect, the inventionincludes a catheter. The catheter includes an elongate body having aproximal end and a distal end, and a retractable sheath mounted on theelongate body proximate the distal end. The sheath and elongate bodycooperate to define a first annularly-shaped compartment between thebody and sheath. The catheter can further include a means, such as afirst linkage, extending from a proximal region of the compartmenttoward the proximal end of the catheter to help deploy a valveprosthesis. The catheter can further include means, such as a secondlinkage, extending from a distal region of the compartment toward theproximal end of the catheter to help deploy a valve prosthesis. Thecatheter further includes a valve prosthesis mounted in the compartment,the prosthesis having a proximal end attached to the first linkage and adistal end attached to the second linkage.

In further accordance with the disclosed embodiments, the catheter mayfurther include a guide for directing the path of travel of the firstlinkage and second linkage to facilitate deployment of the valveprosthesis. The sheath is preferably adapted and configured to beretracted along a longitudinal axis of the catheter to expose the valveprosthesis. The first linkage and second linkage are preferably adaptedand configured to deploy the valve prosthesis when the sheath is in aretracted position by advancing the second linkage in a proximaldirection and by advancing the first linkage in a distal direction.

In accordance with a further aspect, the valve prosthesis is preferablyin a generally longitudinal orientation prior to deployment, and isreoriented into a second, generally arcuate orientation when the secondlinkage is advanced in a proximal direction and when the first linkageis advanced in a distal direction.

In accordance with still a further aspect, the sheath and elongate bodymay cooperate to define a second annularly-shaped compartmenttherebetween, the second annularly-shaped compartment being displacedalong a longitudinal axis of the catheter from the first compartment. Inaccordance with this embodiment, the catheter may further include athird linkage extending from a proximal region of the second compartmenttoward the proximal end of the catheter, a fourth linkage extending froma distal region of the second compartment toward the proximal end of thecatheter, and a second valve prosthesis mounted in the secondcompartment, wherein the second prosthesis has a proximal end attachedto the third linkage and a distal end attached to the fourth linkage.

In further accordance with the disclosed embodiments, the catheter mayfurther include a second guide for directing the path of travel of thethird linkage and fourth linkage to facilitate deployment of the secondvalve prosthesis. The sheath may be adapted and configured to beretracted along the longitudinal axis of the catheter to expose thesecond valve prosthesis. The third linkage and fourth linkage arepreferably adapted and configured to deploy the second valve prosthesiswhen the sheath is in a retracted position by advancing the fourthlinkage in a proximal direction and by advancing the third linkage in adistal direction. The second valve prosthesis is preferably in agenerally longitudinal orientation prior to deployment, and isreoriented into a second, generally arcuate orientation when the fourthlinkage is advanced in a proximal direction and when the third linkageis advanced in a distal direction.

The disclosure further provides a deployable valve prosthesis forreplacing at least a portion of a lumenal valve. The valve prosthesisincludes a deformable body, wherein the deformable body may be arrangedinto a first generally longitudinal orientation suitable for mountingunderneath the retractable sheath of a catheter. The deformable body mayfurther be rearranged into a second orientation that is generallyarcuate.

In further accordance with the disclosed embodiments, the deformablebody may include shape memory material, such as a nickel-titanium alloy.In accordance with another aspect, the deformable body may beconstructed at least in part of a scaffolding material. The deformablebody may have a generally serpentine shape. In accordance with a furtheraspect, the valve prosthesis can further include at least one deployablevalve leaflet attached to the deformable body, wherein the valve leafletis fully deployed upon implantation of the valve prosthesis.

The present disclosure also provides a method for delivering a valveprosthesis. the method includes advancing a distal portion of a catheterto a target location proximate a valve within a patient's lumenalsystem, withdrawing a sheath on the catheter to expose a valveprosthesis, the valve being in a generally longitudinal orientationprior to withdrawing the sheath, and deforming the valve prosthesis fromthe generally longitudinal orientation into a second, generally arcuateorientation.

In accordance with a further aspect of the disclosed embodiments, thevalve prosthesis may be deformed from the generally longitudinalorientation into the generally arcuate orientation by drawing a firstend of the valve prosthesis toward a second end of the valve prosthesis.The valve prosthesis may lie in a plane that is generally parallel tothe longitudinal axis of the catheter when the first end of the valveprosthesis is drawn toward a second end of the valve prosthesis. Themethod can further include the step of rotating the valve prosthesis outof the plane generally parallel to the longitudinal axis of the catheterinto a plane that is generally perpendicular to the longitudinal axis ofthe catheter.

In accordance with a further aspect, the method may further includespreading the valve prosthesis and aligning it with a portion of theannulus of the valve of a patient. In accordance with one embodiment,the existing valve leaflet of the patient may be pushed against thevalve annulus or vessel wall when the valve prosthesis is aligned. Themethod may further include attaching the valve prosthesis to the valveannulus of the patient. In accordance with one embodiment, the installedvalve prosthesis may occupy about half of the circumference of the valveannulus when installed.

In accordance with still a further aspect, the method may furtherinclude installing a second valve prosthesis adjacent the first valveprosthesis, wherein the second valve prosthesis substantially occupiesthe portion of the circumference of the valve annulus not occupied bythe previously installed valve prosthesis.

In accordance with still another embodiment, the first and second valveprostheses may be installed proximate different valves of a patientwithin a given lumen. If desired, the first valve prosthesis may have adifferent size compared to the second valve prosthesis, such as if thedifferent valves of the patent are of different sizes.

It is to be understood that the foregoing general description and thefollowing detailed description are exemplary and are intended to providefurther explanation of the invention claimed.

The accompanying drawings, which are incorporated in and constitute partof this specification, are included to illustrate and provide a furtherunderstanding of the method and system of the invention. Together withthe description, the drawings serve to explain principles of theinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional view of a first exemplary embodiment of acatheter made in accordance with the present disclosure.

FIG. 2 is a cross-sectional view of a second exemplary embodiment of acatheter made in accordance with the present disclosure.

FIG. 3 is a cross sectional view of a portion of the exemplaryembodiment of FIG. 2.

FIG. 4(A) depicts a first aspect of an exemplary method of delivering aprosthesis in accordance with the present disclosure.

FIG. 4(B) depicts a second aspect of an exemplary method of delivering aprosthesis in accordance with the present disclosure.

FIG. 5 depicts a third aspect of an exemplary method of delivering aprosthesis in accordance with the present disclosure.

FIG. 6 depicts a fourth aspect of an exemplary method of delivering aprosthesis in accordance with the present disclosure.

FIG. 7 depicts an exemplary valve prosthesis made in accordance with thepresent disclosure in a deployed condition.

FIG. 8 depicts a view of an exemplary prosthesis installed in a valve ofan animal heart resulting in a partial valve replacement.

FIG. 9 depicts a view of an exemplary prosthesis installed in the valveof an animal heart in a first portion of a complete valve replacementprocedure.

FIG. 10 depicts two exemplary prostheses installed as a part of acomplete valve replacement in an animal heart.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Reference will now be made in detail to the present preferredembodiments of the invention, examples of which are illustrated in theaccompanying drawings. The method and corresponding steps of theinvention will be described in conjunction with the detailed descriptionof the system.

As mentioned above, there is a continuing need for improved valveprostheses and associated devices and methods for delivery. As anillustrative non-limiting example, devices and associated methodsdescribed herein may be used to treat, among other things, vascularvalve dysfunction and/or insufficiency in patients with Congestive HeartFailure (CHF) and or venous leg edema with symptoms that may include,for example, mitral regurgitation and venous insufficiency. In suchcases, valve dysfunction occurs because of dilation, or enlargement, ofthe heart and/or veins and causes dysfunction of the valves. Venousinsufficiency leads to edema of the legs while mitral regurgitationleads to decreased ventricular function. These conditions necessitate aneed for less invasive procedures. Percutaneous procedures enable a nonsurgical approach to treat symptoms via a partial or complete valvereplacement in a stepwise fashion. Current percutaneous procedures andor devices are limited in their ability to treat the full potentialpatient populations. Notably, it is observed herein that a partialand/or complete replacement may provide potential benefit over surgicaland percutaneous methods for repair or complete replacement.

Current procedure requires one to two access points from the femoral. Inaccordance with the disclosed embodiments, it is possible to usepercutaneous approaches to partially or completely replace heart valvesor venous valves with a valve prosthesis by way of a transceptal or froma femoral retrograde approach. Using such approaches it becomespossible, for example, to achieve a partial or complete replacement ofthe mitral valve in a stepwise fashion using percutaneous methods.

The approaches herein may be used, for example, for treatment ofpatients with class I and Class 2 CHF. These classes of patientscurrently are not good surgical candidates. Opportunities thus exist totreat these patients percutaneously and in conjunction with otherpercutaneuous procedures. Patients with venous edema represent asignificantly larger patient population than CHF. Current methods totreat edema include pressure bandages in order to elevate symptoms. Itis believed that the disclosed embodiments provide a novel approach thatcan correct valve dysfunction.

Thus, in accordance with one aspect of the disclosed embodiments, acatheter is provided including an elongate body, a retractable sheath,and including a deployable valve prosthesis.

For purpose of explanation and illustration, and not limitation, apartial view of an exemplary embodiment of a catheter in accordance withthe present disclosure is shown in FIG. 1 and is designated generally byreference character 100. Other aspects of catheters and associatedmethods in accordance with the present disclosure, or aspects thereof,are provided in FIGS. 2-12, as will be described.

As depicted in FIG. 1, catheter 100 includes an elongate body 110 havinga proximal end 112, a distal end 114, and a retractable sheath 120mounted on the elongate body 110 proximate the distal end 114. Thesheath 120 and elongate body 120 cooperate to define a firstannularly-shaped compartment 130 between the body and sheath forreceiving a valve prosthesis 200, described in detail below.

As further depicted in FIG. 1, the catheter 100 includes means tofacilitate deploying the valve prosthesis 200. For purposes ofillustration and not limitation, as illustrated herein, such means inpart includes a first linkage 140. First linkage 140 extends from aproximal region 132 of the compartment 130 toward the proximal end 102of the catheter 100 to help deploy valve prosthesis 200. As depicted inFIG. 1, catheter 100 further includes a second linkage 150 extendingfrom a distal region 134 of the compartment 130 toward the proximal end102 of the catheter 100 to help deploy the valve prosthesis 200.

As depicted in FIG. 1, catheter 100 further includes a valve prosthesis200 mounted in the compartment 130, the prosthesis having a proximal end202 attached to the first linkage 140 and a distal end 204 attached tothe second linkage 150. Prosthesis 200, as illustrated, is presented asa valve prosthesis. Other embodiments of prostheses are described below.In an undeployed state, prosthesis 200 is in a generally longitudinalconfiguration. However, during and after deployment, as illustrated inFIGS. 4(B)-7, prosthesis 200 has a generally annular configuration. Asdepicted in FIG. 7, upon deployment, prosthesis includes a peripheralregion 206 including reinforcing structural material 212 such asscaffolding, and a leaflet 208 having an edge 209 made, for example,from a polymeric membrane 216. The structural material may includemetallic and/or polymeric materials. Preferably, structural material 212includes shape memory material, such as various alloys of nickel andtitanium. It will be recognized that a variety of structures can be usedfor structural material 212 without departing from the spirit or scopeof the disclosed embodiments. Concerning membrane 216, a variety ofbiocompatible materials can be used, such as ePTFE described, forexample, in U.S. Pat. No. 6,436,135, which is incorporated by referenceherein it its entirety. A variety of other polymeric, composite orbiological materials may be used. For example, if desired, cellularcontent may be used and/or structural components from cadavers may beused as long as the materials are suitable for implantation.

As further depicted in FIG. 1, catheter 100 may further include a guide160 for directing the path of travel of the first linkage 140 and secondlinkage 150 to facilitate deployment of the valve prosthesis 200. Asdepicted, guide 160 is generally bell-shaped, and acts to cause linkages140, 150 to splay apart during deployment of prosthesis 200 to helpprosthesis 200 to take on an arcuate shape. Particularly, a pull wire162 or similar structure can be provided to advance guide 160 proximallyto facilitate deployment. However, it will be recognized that guide 160need not be provided. Instead, if shape memory material is used to makeprosthesis 200 and/or linkages 140, 150, deployment may be facilitatedby such components changing shape by retracting sheath 120 proximallyand by manipulating linkages 140, 150 along a proximal/distal direction,as well as rotationally.

Linkages 140, 150 (and 240, 250, described below) may be made from avariety of materials, such as hypotubes made from stainless steel (andhaving a very small profile), or may be solid metallic or compositemembers, such as carbon fiber reinforced materials. As depicted in FIG.3, inner member 110 may include a variety of lumens along its length,such as for advancing or retracting linkages 140, 150 (and 240, 250), aswell as for pull wire 162, or for a guidewire. Specifically, a guidewirelumen 118 is provided, if desired. It will also be recognized thatcatheter 100 can be delivered in a guiding catheter, and need not beprovided with its own guidewire lumen 118.

Referring again to FIG. 1, sheath 120 is preferably adapted andconfigured to be retracted along a longitudinal axis of the catheter toexpose the valve prosthesis using an actuator 170, described in moredetail below. The first linkage 140 and second linkage 150 arepreferably adapted and configured to deploy the valve prosthesis 200when the sheath 120 is in a retracted position by advancing the secondlinkage 150 in a proximal direction and by advancing the first linkage140 in a distal direction. The method of deployment of valve prosthesis200 using catheter 100 is described in detail below.

In accordance another embodiment, as depicted in FIG. 2, if desired, itis possible to provide a second deployable valve prosthesis 300. Themeans for retaining, releasing and delivering the second prosthesis maybe very similar to the first prosthesis 200. The same sheath 120 may beused to house the second prosthesis 300 in cooperation with the elongatebody 110 to define a second compartment 260 to store the prosthesisuntil it is deployed. In accordance with this embodiment, the cathetermay further include a third linkage 240 extending from a proximal regionof the second compartment 230 toward the proximal end 102 of thecatheter and a fourth linkage 250 extending from a distal region of thesecond compartment 230 toward the proximal end of the catheter. Asdepicted, the second prosthesis 300 has a proximal end 302 attached tothe third linkage 240 and a distal end 304 attached to the fourthlinkage 250.

Concerning the relative positioning of multiple prostheses on catheter100, prostheses 200, 300 may be disposed in opposite orientations fromone another rotationally. As depicted, for sake of convenience,prostheses are disposed on catheter 100 at a relative rotation of 90degrees to permit linkages 140, 150, 240, 250 to each occupy a lumen(142, 152, 242, 252) in a different quadrant of the cross section ofelongate body 110 as depicted in FIG. 3.

Elongate body 110 may be made in a variety of ways and from a variety ofmaterials. For example, elongate body 110 may be made from a variety ofmaterials, including metal, plastic and composite materials. Metal tubessuch as stainless steel hypotubes can be used for one or more portionsof elongate body 110 for enhanced pushability alone or in combinationwith other suitable materials. For example, FIG. 3 discloses a crosssection of the elongate body 110 of the exemplary catheter illustratedin FIGS. 1-2, including a plurality of lumens that may be used fordirecting linkages to the distal region of the catheter. If metaltubular components are used to make elongate body 110, they arepreferably coated with a lubricious material such as PTFE, otherhydrophobic materials or hydrophilic materials. Multilayered polymerictubes can also be used to form elongate member 110 that can be formed bycoextrusion, dipping processes, or by shrinking tubing layers over oneanother over a mandrel. Moreover, polymeric tubular members can also beformed by charging a mandrel with static electricity, applying plasticin powder or granular form to the mandrel to form a layer of plasticover the mandrel, and by heating the mandrel to cause the particles tofuse. Multilayered polymeric tubes can also be used that includemetallic or nonmetallic braiding within or between layers of the tube. Acarbon tube can also be used, as well as fiber-reinforced resinmaterials. In accordance with another embodiment, elongate body 110 maybe provided with a decreasing stiffness along its length from proximalend 112 to distal end 114. As will be further appreciated by those ofskill in the art, elongate body 110 may include a multiple-lumenextrusion including two, three, four, or more lumens along part of orsubstantially the entire length of elongate body 110 as depicted in FIG.3. Moreover, stiffening wires can be used at various locations alongelongate body to provide stiffness transitions between relativelystiffer regions and less stiff regions, as well as proximate regions ofstress concentration, such as guidewire exit ports and the like. Inaccordance with one embodiment, a guidewire lumen 118 is provided alongsubstantially the entire length of elongate body 110 as with typicalover the wire (“OTW”) catheters. In accordance with another embodiment,a guidewire lumen 118 is provided only proximate the distal region ofelongate body 110 to permit use of catheter 100 as a rapid exchange“RX”) catheter.

Sheath 120 may be made from a variety of materials. Preferably, sheath120 includes a multi-layered co-extrusion, such as those described inU.S. Pat. No. 6,464,683 to Samuelson or U.S. Pat. No. 5,538,510 toFontirroche. Each of the aforementioned patents is incorporated byreference herein in its entirety.

As further depicted in FIG. 1, an actuator 170 is provided forselectively retracting sheath 120. Actuator 170 can take on a variety offorms, such as those depicted in U.S. Pat. No. 6,488,694 to Lau and U.S.Pat. No. 5,906,619 to Olson, the specifications of which areincorporated herein by reference. In addition, as depicted in FIGS. 1-2,a manifold 180 is provided including a plurality of actuators 181-184for controlling linkages 140, 150, 240, 250. However, as will beappreciated, manifold may also include flush ports 190 for preparing orcleaning catheter 100.

Any surface of various components of the catheters described herein orportions thereof can be provided with one or more suitable lubriciouscoatings to facilitate procedures by reduction of frictional forces.Such coatings can include, for example, hydrophobic materials such asPolytetrafluoroethylene (“PTFE”) or silicone oil, or hydrophiliccoatings such as Polyvinyl Pyrrolidone (“PVP”). Other coatings are alsopossible, including, echogenic materials, radiopaque materials andhydrogels, for example.

The present disclosure also provides methods for delivering a valveprosthesis. In accordance with one illustrative embodiment, reference ismade to the embodiment of FIG. 1. First, with reference to FIG. 4(A),the method includes advancing a distal portion 115 of a catheter 100 toa target location proximate a valve within a patient's lumenal system.The method further includes withdrawing a sheath 120 on the catheter 100to expose a valve prosthesis 200, the valve prosthesis 200 being in agenerally longitudinal orientation prior to withdrawing the sheath 120.Next, as illustrated in FIG. 4(B), the valve prosthesis is deformed froma pre-deployment, generally longitudinal orientation, into a second,generally arcuate orientation. In the embodiment of FIG. 4(B), this isaccomplished by advancing linkage 140 distally, and advancing linkage150 proximally. As can be seen this results in the first end 202 of thevalve prosthesis 200 being drawn toward second end 204 of the valveprosthesis 200. As depicted in FIG. 4(B), the valve prosthesis 200 maylie in a plane that is generally parallel to the longitudinal axis X ofthe catheter when the first end 202 of the valve prosthesis 200 is drawntoward the second end 204 of the valve prosthesis 200.

As illustrated in FIG. 5, the method can further include the step ofrotating the valve prosthesis 200 out of the plane generally parallel tothe longitudinal axis of the catheter into a plane that is generallyperpendicular to the longitudinal axis of the catheter. As illustratedin FIG. 5, at this point, linkages 140, 150 are about the same distancefrom the proximal end of the catheter, but guide member 160 has not yetbeen fully actuated to continue deployment.

As depicted in FIG. 6, the method may further include deploying a guidemember (e.g., 160 by pulling pull wire 162), to cause linkages 140, 150to splay outwardly to cause prosthesis 200 to fully deploy into acondition illustrated in FIG. 7. At this point, prosthesis 200 can bepositioned within a patient's valve annulus and secured by variousretainers, such as sutures and clips. In accordance with one embodiment,prosthesis may simply be installed over the patient's existing valveleaflet, causing the pre-existing leaflet to be pinned to the side ofthe vessel wall. Once properly installed, edge 209 of leaflet 208 willsubstantially align with the adjoining pre-existing leaflet. However, ifdesired, a second prosthesis 300 may be installed proximate the firstprosthesis to accomplish a full replacement. The second prosthesis 300may be provided by using a catheter made in accordance with theteachings relating to FIG. 2 herein, or simply by using a secondcatheter made in accordance with the teachings relating to FIG. 1.

As will be appreciated by those of skill in the art, a variety ofprocedures may be accomplished using the teachings herein. For example,a catheter made in accordance with the teachings relating to FIG. 2herein to perform partial valve replacements at adjacent valves in apatient's vein, such as for treating leg edema. Accordingly, the valveprostheses can be provided in different sizes to allow for the reductionin size in sequential venous valves to permit one catheter to be used tomake two valve replacements.

FIGS. 8-10 illustrate partial and complete valve replacement usingembodiments of prosthesis made and installed in accordance with thepresent disclosure. FIG. 8 depicts a view of an exemplary prosthesisinstalled in a cardiac valve, such as a mitral valve, of an animalheart. The procedure depicted in FIG. 8 is one where a single prosthesis200 is installed, replacing only one of the valve leaflets. FIGS. 9-10depicts a ventricular view of a similar procedure, but wherein bothleaflets are replaced. In particular, FIG. 9 illustrates a singleprosthesis installed, replacing one half of the valve, with the leafletcorresponding to the other half of the original valve being removed.FIG. 10 illustrates the addition of second valve prosthesis 300,resulting in a complete valve replacement, such as a mitral valvereplacement. If desired, artificial valve chordae 273, 373 (such assutures made of ePTFE or other suitable material) can be provided toconnect the exposed edges 209, 309 of the leaflets to original chordae,or the papillary muscle where the original valve chordae were anchored.

As will be appreciated by those of skill in the art, the deliverycatheters and associated methods described herein may be used to delivera variety of devices within the lumenal system of a patent. Inparticular, such catheters and methods can be used whenever it isdesired to deliver a device in a generally elongate form that is lateroriented into a generally arcuate form. This approach permits deliveryof relatively large devices, such as replacement valves for largelumens, on comparatively smaller profile catheters than used heretoforein the art. As such, it will be appreciated that such catheters andmethods can be used to deliver such implants adapted (e.g., sized) forother applications, such as veins, arteries, the gastrointestinal tract,or any other body conduit/lumen that would benefit from such a valveapparatus.

The methods and systems of the present invention, as described above andshown in the drawings, provide for improved devices and methods forreplacement of lumenal valves. It will be apparent to those skilled inthe art that various modifications and variations can be made in thedevice and method of the present invention without departing from thespirit or scope of the invention. Thus, it is intended that the presentinvention include modifications and variations that are within the scopeof the appended claims and their equivalents.

1. A catheter comprising: a) an elongate body having a proximal end and a distal end; b) a retractable sheath mounted on the elongate body proximate the distal end, the sheath and elongate body cooperating to define a first annularly-shaped compartment therebetween; c) a first linkage extending from a proximal region of the compartment toward the proximal end of the catheter; d) a second linkage extending from a distal region of the compartment toward the proximal end of the catheter; and e) a valve prosthesis mounted in the compartment, the prosthesis having a proximal end attached to the first linkage and a distal end attached to the second linkage.
 2. The catheter of claim 1, further comprising a guide for directing the path of travel of the first linkage and second linkage to facilitate deployment of the valve prosthesis.
 3. The catheter of claim 1, wherein the sheath is adapted and configured to be retracted along a longitudinal axis of the catheter to expose the valve prosthesis.
 4. The catheter of claim 1, wherein the first linkage and second linkage are adapted and configured to deploy the valve prosthesis when the sheath is in a retracted position by advancing the second linkage in a proximal direction and by advancing the first linkage in a distal direction.
 5. The catheter of claim 4, wherein the valve prosthesis is in a generally longitudinal orientation prior to deployment, and is reoriented into a second, generally arcuate orientation when the second linkage is advanced in a proximal direction and when the first linkage is advanced in a distal direction.
 6. The catheter of claim 1, wherein the sheath and elongate body cooperate to define a second annularly-shaped compartment therebetween, the second annularly-shaped compartment being displaced along a longitudinal axis of the catheter from the first compartment.
 7. The catheter of claim 6, wherein the catheter further comprises: a) a third linkage extending from a proximal region of the second compartment toward the proximal end of the catheter; b) a fourth linkage extending from a distal region of the second compartment toward the proximal end of the catheter; and c) a second valve prosthesis mounted in the second compartment, the second prosthesis having a proximal end attached to the third linkage and a distal end attached to the fourth linkage.
 8. The catheter of claim 7, further comprising a second guide for directing the path of travel of the third linkage and fourth linkage to facilitate deployment of the second valve prosthesis.
 9. The catheter of claim 7, wherein the sheath is adapted and configured to be retracted along the longitudinal axis of the catheter to expose the second valve prosthesis.
 10. The catheter of claim 7, wherein the third linkage and fourth linkage are adapted and configured to deploy the second valve prosthesis when the sheath is in a retracted position by advancing the fourth linkage in a proximal direction and by advancing the third linkage in a distal direction.
 11. The catheter of claim 10, wherein the second valve prosthesis is in a generally longitudinal orientation prior to deployment, and is reoriented into a second, generally arcuate orientation when the fourth linkage is advanced in a proximal direction and when the third linkage is advanced in a distal direction.
 12. A deployable valve prosthesis for replacing at least a portion of a lumenal valve, the valve prosthesis including a deformable body, wherein: a) the deformable body may be arranged into a first generally longitudinal orientation suitable for mounting underneath the retractable sheath of a catheter; and wherein b) the deformable body may be rearranged into a second orientation that is generally arcuate.
 13. The deployable valve prosthesis of claim 12, wherein the deformable body includes shape memory material.
 14. The deployable valve prosthesis of claim 13, wherein the shape memory material includes a nickel-titanium alloy.
 15. The deployable valve prosthesis of claim 12, wherein the deformable body is constructed at least in part of a scaffolding material.
 16. The deployable valve prosthesis of claim 15, wherein the deformable body has a generally serpentine shape.
 17. The deployable valve prosthesis of claim 12, wherein the valve prosthesis further includes at least one deployable valve leaflet attached to the deformable body, wherein the valve leaflet is fully deployed upon implantation of the valve prosthesis.
 18. The deployable valve prosthesis of claim 12, wherein the prosthesis includes biological material.
 19. The deployable valve prosthesis of claim 18, wherein the biological material includes material obtained from a cadaver.
 20. The deployable valve prosthesis of claim 18, wherein the biological material includes cellular content.
 21. A method for delivering a valve prosthesis, comprising: a) advancing a distal portion of a catheter to a target location proximate a valve within a patient's lumenal system; b) withdrawing a sheath on the catheter to expose a valve prosthesis, the valve being in a generally longitudinal orientation prior to withdrawing the sheath; c) deforming the valve prosthesis from the generally longitudinal orientation into a second, generally arcuate orientation.
 22. The method of claim 21, wherein the valve prosthesis is deformed from the generally longitudinal orientation into the generally arcuate orientation by drawing a first end of the valve prosthesis toward a second end of the valve prosthesis.
 23. The method of claim 22, wherein the valve prosthesis lies in a plane that is generally parallel to the longitudinal axis of the catheter when the first end of the valve prosthesis is drawn toward a second end of the valve prosthesis.
 24. The method of claim 21, further comprising rotating the valve prosthesis out of the plane generally parallel to the longitudinal axis of the catheter into a plane that is generally perpendicular to the longitudinal axis of the catheter.
 25. The method of claim 22, further comprising spreading the valve prosthesis and aligning it with a portion of the annulus of the valve of a patient.
 26. The method of claim 23, wherein the existing valve leaflet of the patient is pushed against the valve annulus or vessel wall when the valve prosthesis is aligned.
 27. The method of claim 24, further comprising attaching the valve prosthesis to the valve annulus of the patient.
 28. The method of claim 25, wherein the installed valve prosthesis occupies about half of the circumference of the valve annulus when installed.
 29. The method of claim 26, further comprising installing a second valve prosthesis adjacent the first valve prosthesis, wherein the second valve prosthesis substantially occupies the portion of the circumference of the valve annulus not occupied by the previously installed valve prosthesis. 